Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis

Phase 3

Completed

• Conditions: Osteoarthritis

• Registration Number: NCT00171665
• Lead Sponsor: Novartis

Brief Summary

This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of hand osteoarthritis.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-15
• Study Completion: 2005-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-13
• Last Update Posted: 2015-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

Not provided

Exclusion Criteria

• Other rheumatic disease, such as rheumatoid arthritis
• Active gastrointestinal ulcer during the last year
• Known allergy to analgesic drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
OA pain intensity in target hand at Week 4 and 6
Global rating of disease activity by patient at Week 4 and 6
Total AUSCAN score in target hand at Week 4 and 6

Secondary Outcome Measures

Name	Time	Method
Global evaluation of treatment at final visit
AUSCAN pain, stiffness and physical function scores in target hand, and global rating of benefit by patient at Weeks 1, 2, 4, 6 and 8
OA pain intensity and total AUSCAN score in target hand, and global rating of disease activity by patient at Weeks 1, 2 and 8
OA pain intensity in target hand and use of rescue medication recorded in diary
Treatment responder rate according to OARSI criteria

Trial Locations

Locations (69)

Alabama Clinical Therapeutics; 🇺🇸 Birmingham, Alabama, United States

MedSearch, LLC; 🇺🇸 Calera, Alabama, United States

Montgomery Rheumatology Associates; 🇺🇸 Montgomery, Alabama, United States

Drug Research & Analysis Corp; 🇺🇸 Montgomery, Alabama, United States

Arizona Center for Clinical Research; 🇺🇸 Glendale, Arizona, United States

Quality of Life Medical Research Center, LLC; 🇺🇸 Tucson, Arizona, United States

Lovelace Scientific Resources, Inc.; 🇺🇸 Beverly Hills, California, United States

Med Investigations/Med Center; 🇺🇸 Carmichael, California, United States

H. Richard Barthel,MD, Inc.; 🇺🇸 Santa Barbara, California, United States

Clinical Research of CT/NY; 🇺🇸 Danbury, Connecticut, United States

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